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news.Piramal Pharma Solutions and NewAmsterdam Pharma have announced the inauguration of an oral solid dosage (OSD) suite at the former’s facility located in Sellersville, Pennsylvania, US.
Unveiling of the dedicated OSD suite at the Sellersville facility. Credit: Piramal Pharma Solutions/PRNewswire.
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The investment equips NewAmsterdam Pharma with the commercial capability to produce a fixed dose combination (FDC) of obicetrapib and ezetimibe, thereby addressing potential market demand.
Piramal Pharma Solutions utilised two additional facilities to manufacture the FDC.
The Sellersville facility offers development and manufacturing services for a range of formulations, including multiple OSD forms.
This enhancement will boost operational efficiency, assisting NewAmsterdam Pharma in delivering its investigational drug therapy to patients in need, should it receive approval.
The suite signifies an investment in the upgrading and enhancement of equipment to bolster the site’s capabilities.
This involves reconfiguring the existing space to establish a dedicated OSD suite, which will be exclusively utilised for FDC products.
The newly designed suite is tailored for multi-layer tablet production and is equipped with advanced technology to support processes such as granulation, compression, tableting and coating.
This facility will support the production of NewAmsterdam Pharma’s investigational FDC, a non-statin cholesterol medication designed to lower LDL-C levels.
The collaboration between Piramal Pharma Solutions and NewAmsterdam Pharma goes beyond the Sellersville location. Piramal’s Ahmedabad PPDS site in India contributed to the product’s development, and its Pithampur site offers dual sourcing support.
Piramal Global Pharma CEO Peter DeYoung said: “We are thrilled to expand our OSD production capabilities at the Sellersville facility with this new manufacturing suite.
“This addition will not only enhance our production capacity and speed, but reinforce our commitment to patient centricity, too.”
Over the next five years, the suite is anticipated to generate over 20 new jobs at the Sellersville location.
